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Personalizing enzalutamide (Xtandi®) therapy by understanding the relation between the decrease in the expression profile of a panel of preselected microRNAs, tumor related mRNAs and treatment response in patients with mCRPC (ILUMINATE)

Primary Objectives:To explore whether the decrease in a panel of early easily assessable biomarkers (PSA-mRNA, PCA3-mRNA and TMPRSS2:ERG gene fusion-mRNA, (currently under development) ARv7 mRNA, ARwt mRNA, miR-21, miR-141, miR-200a, miRrumc95,…

Randomised Controlled Study on the Effects of Imiquimod, a TLR 7 Activating Agent, on the HPV16-Specific Immune Response Following HPV16 E6/E7 Synthetic Long Peptides Vaccination in Women with HPV16 Positive High Grade Vulvar/Vaginal Intraepithelial Neoplasia.

Primary objective:To compare the immunological response to vaccination with HPV16 E6 and E7 synthetic long peptides with concomitant application of imiquimod at the vaccination site with vaccination without the concomitant application of imiquimod.…

A PHASE I, OPEN-LABEL STUDY OF THE SAFETY AND PHARMACOKINETICS OF ESCALATING DOSES OF DMOT4039A IN PATIENTS WITH UNRESECTABLE PANCREATIC OR PLATINUM-RESISTANT OVARIAN CANCER

The primary objectives of this study are the following:• To evaluate the safety and tolerability of DMOT4039A when administered every 3 weeks or weekly to patients with unresectable pancreatic or platinum-resistant ovarian cancer• To determine the…

A Randomized, Open Label, Phase III, Multicenter, 2-Arm Study of Androgen deprivation +/- Taxoterere* (Docetaxel) for Non metastatic Prostate Cancer Patients with a Rising PSA.

To evaluate and compare progression free survival (PSA) between the two treatment arms.

The effects of neoadjuvant hormonal therapy on the course of PSA and testosterone in patients with low and intermediate risk prostate carcinoma (NEO-ONE)

To assess the effects of 3-month NHT on the 3-year course of PSA and testosterone in patients treated with BT for low-intermediate risk clinically localized prostate carcinoma. In addition, we would like to assess the effects of 3-month NHT on…

An Open-Label, Multi-Centre, Uncontrolled, Trial Investigating Degarelix One-Month Dosing Regimen Administered as Intermittent Androgen Deprivation (IAD) for One or More Cycles in Patients with Prostate Cancer Requiring Androgen Deprivation Therapy

Primary Objective - To evaluate the time to PSA >4 ng/mL during the first cycle of IAD after the end of an induction period with degarelix (7 monthly treatments) in prostate cancer patientsSecondary Objectives - To evaluate the time to PSA .4…

Therapeutic Drug Monitoring to Individualize the Dosing of pazopanib: a Randomized Pharmacokinetic Feasibility Study

Primary objectiveTo evaluate the effect of PK-guided individualized dosing of pazopanib on the interindividual variability in drug exposure.Secondary objective- To determine the correlation between pazopanib trough and exposure levels - To determine…

Safety, efficacy and immunogenicity of HPV 16 E7 DNA vaccination in HPV related squamous cell cancer.

To study the toxicity, efficacy and immunogenicity of naked DNA vaccines encoding the shuffled HPV 16 E7 gene products (TTFC-E7SH) in advanced-stage patients with squamous cell carcinoma of the anogenital or the head and reck region.

Prospective multi-centre study of low-dose Iodine125 (I-125) prostate brachytherapy performed after transurethral resection. PROBATE study

To test in a prospective study the feasibility and outcome of low dose rate I-125 seed brachytherapy to treat early low risk prostate cancer in patients who have had previous TURP using specific recommendations on target and organs at risk dose…

SEMINAL VESICLE MOTION RELATIVE TO THE PROSTATE

To quantify the motion of the seminal vesicles.

Phase II multi-centric, randomised, open-label, parallel-group study to assess the non-inferiority of Pamorelin® 11,25 mg SC injected versus Pamorelin® 11,25 mg IM injected in patients suffering from advanced prostate cancer

Primary Study ObjectiveTo assess the non-inferiority of the 12-week triptorelin formulation Pamorelin® 11,25 mg administered via subcutaneous (SC) injection as compared to Pamorelin® 11,25 mg administered via registered intramuscular (IM) injection…

Prostate cancer and diet - a randomized controlled trial on the effect of a dietary intervention on the quality of life of men and serum nutrient levels in their blood.

Primary objective: to improve participants* quality of life, as measured by the SF-12 general health domain, by actively engaging in a prostate cancer diet. Secondary objectives: - To improve participants* feeling of being in control of their…

Registry of Treatment Outcomes in a non-study population of Symptomatic Metastasized Castration Resistant Prostate Cancer (mCRPC) Patients Treated with Radium-223 (ROTOR-registry).

1.To evaluate the efficacy of Radium-223 treatment in a non-study population by effects on Symptomatic Skeletal Event (SSE)2. Evaluate Radium-223 treatment efficacy by patient reported analgesic use and pain outcome3. Evaluate Radium-223 treatment…

A Phase I/II Study of TheraT® Vector(s) Expressing Human Papillomavirus 16 Positive (HPV 16+) Specific Antigens in Patients with HPV 16+ Confirmed Cancers

Phase I Dose Escalation1.To determine the RP2D in terms of safety and tolerability for:•IV admin of HB-201 in patients with HPV 16+ confirmed HNSCC•IT admin of HB-201 in patients with HPV 16+ confirmed cancers•IV admin of HB-202 in patients with HPV…

Testosterone based dosing regimen of goserelin in patients with prostate cancer

The primary objective is to determine in which percentage of patients with prostate cancer with an indication for ADT, it is safe to extend the dosing interval of goserelin 10,8 mg by four weeks, before the 4th injection, using a testosterone based…

Sentinel lymph node procedure in patients with recurrent vulvar squamous cell carcinoma. A multicentre observational study.

The primary objective is to investigate the safety of replacing complete IFL by the SLN procedure in patients with local recurrent vulvar squamous cell carcinoma without suspicious groin lymph nodes.

A Multicentre Phase II Study of AZD1775 plus Chemotherapy in Patients with Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer.

Primary objective:To evaluate the objective response rate (ORR) of AZD1775 in combination with gemcitabine, carboplatin, paclitaxel,or PLD in patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancerSecondary…